Article(id=1291707120219615591, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707045514858818, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.23.011, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1749052800000, receivedDateStr=2025-06-05, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896576217, onlineDateStr=2026-08-05, pubDate=1765900800000, pubDateStr=2025-12-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896576217, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896576217, creator=13701087609, updateTime=1785896576217, updator=13701087609, issue=Issue{id=1291707045514858818, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='23', pageStart='3301', pageEnd='3450', issueExtLink='null', onlineDate='null', pubDate='1765900800000', pubDateStr='2025-12-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896558407, creator='13701087609', updateTime=1785896663780, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707487678390577, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707045514858818, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707487682584882, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707045514858818, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3374, endPage=3381, ext={EN=ArticleExt(id=1291707122421625192, articleId=1291707120219615591, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Strategies and key considerations for weight-of-Evidence (WoE) assessment of drug carcinogenicity risk under ICH S1B(R1), columnId=1246531408630534361, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Review, runingTitle=null, highlight=null, articleAbstract=

The ICH S1B(R1) guideline addendum, adopted by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in August 2022, introduces a comprehensive Weight of Evidence (WoE)-based approach into the traditional framework for drug carcinogenicity risk assessment. This method aims to conduct an integrated analysis by incorporating multiple key factors to evaluate whether the two-year rat carcinogenicity study can provide additional valuable information for human carcinogenicity risk assessment. Consequently, under certain circumstances, the two-year rat carcinogenicity study may be waived, allowing resources to be focused on more scientific, mechanism-based carcinogenicity assessments. This transformation is grounded in scientific advances since the release of ICH S1B in 1997, retrospective analyses of drug databases, and an international prospective study, confirming that the WoE approach can adequately assess risks in specific contexts and aligns with the 3R principles (Replacement, Reduction, Refinement) aimed at reducing animal use. The addendum emphasizes a systematic evaluation of factors such as target biology, secondary pharmacology, histopathology from long-term toxicity studies, hormonal effects, genotoxicity, and immunomodulation, encouraging a mechanism-driven risk assessment strategy. However, its implementation faces scientific and procedural challenges, and there may be disagreements between regulatory authorities and applicants regarding WoE conclusions. Promoting practical application requires early communication, standardized documentation submission, and international experience sharing. Although current implementation experience is limited and both regulators and industry remain cautious, coordinated efforts by the ICH Implementation Working Group (IWG) and accumulating case studies are expected to advance WoE-based carcinogenicity assessment, optimize drug development processes, reduce unnecessary animal testing, and foster the safe and ethical development of innovative drugs.

, authors=Yu ZHOU, Fang-hua HUANG, Tao SUN, authorsList=Yu ZHOU, Fang-hua HUANG, Tao SUN, authorCompany=null, correspAuthors=Tao SUN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291707123239514473, articleId=1291707120219615591, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=ICH S1B(R1)指导原则药物致癌性风险证据权重（WoE）评估的策略及关注点, columnId=1246531408819278046, journalTitle=中国临床药理学杂志, columnName=综述, runingTitle=null, highlight=null, articleAbstract=

人用药品注册技术要求国际协调会（ICH）于2022年8月通过的ICH S1B（R1）指导原则增补，在传统药物致癌性风险评估框架中引入了基于证据权重（WoE）的综合方法。该方法旨在通过整合多个关键因素，综合分析2年大鼠致癌性试验是否能够为人体致癌性风险评估提供更多有价值的信息，从而在某些情况下豁免2年大鼠致癌性试验，将资源集中到更加科学的、基于机制的致癌性评估上。这一变革基于自1997年ICH S1B发布以来的科学进步、对药物数据库的回顾性分析以及一项国际前瞻性研究，证实了WoE方法在特定情况下可充分评估风险，符合减少动物使用的3R原则（减少/优化/替代）。该增补强调对靶点生物学、次要药理学、长期毒性试验的组织病理学、激素效应、遗传毒性和免疫调节等因素进行系统评价，鼓励采用机制驱动的风险评估策略。然而，其实施面临科学与流程挑战，监管机构与申请人对WoE结论可能存在分歧，需通过早期沟通、标准化文件提交及国际经验共享等以推动实践落地。尽管当前实施经验有限且监管机构和行业均持谨慎态度，但随着ICH实施工作组（IWG）的协调推进和案例积累，基于WoE的致癌性评估有望优化药物开发进程，减少非必要动物试验，促进创新药安全并合乎伦理的开发。

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周宇（1986-），男，硕士，主要从事药品技术审评工作

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周宇（1986-），男，硕士，主要从事药品技术审评工作

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